Clinical Research Regulatory Coordinator

6 days ago


Newport Beach, California, United States Russell Tobin Full time
Overview

Russell Tobin is seeking an experienced Clinical Research Regulatory Coordinator to support the company's regional health care delivery network.

About the Role

This senior role will provide critical support to clinical research teams, ensuring compliance with regulations and facilitating the study start-up approval process. The successful candidate will have a deep understanding of current federal, state, and local regulations regarding clinical research and will be able to communicate changes effectively to the study team.

Key Responsibilities
  • Ensure all research studies are compliant with regulations and maintain accurate and up-to-date regulatory files.
  • Track each protocol through the IRB/subcommittee approval process and develop systems to decrease delay in the approval process.
  • Work closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.
Requirements
  • Bachelor's Degree required.
  • Minimum 5 years of regulatory documentation experience in clinical research.
  • 30-50 clinical trials completed at minimum.
  • Experience with opening trials, filing applications and submissions for Phase 1 trials.
  • FDA and IRB start-up experience.
Salary and Benefits

The salary for this position is estimated to be between $37.38 and $57.46 per hour, depending on experience. Additionally, Russell Tobin offers a comprehensive benefits package, including opportunities for career growth and development.



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